Commission Regulation (EC) No 976/2008 of 6 October 2008 amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive Clinacox , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)
Date: 2008-10-06
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, laying poultry, market approval, poultry, veterinary drug

7.10.2008

EN

Official Journal of the European Union

L 266/3

COMMISSION REGULATION (EC) No 976/2008

of 6 October 2008

amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the
terms of the authorisation of the feed additive ‘Clinacox’, belonging to the group of coccidiostats
and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 13(3) thereof,

Whereas:

(1)

(2)

The additive diclazuril (Clinacox 0,5 % Premix), belonging
to the group of coccidiostats and other medicinal
substances, was authorised under certain conditions in
accordance with Council Directive 70/524/EEC (2).
Commission Regulations (EC) No 2430/1999 (3),
(EC)
No 418/2001 (4) and (EC) No 162/2003 (5) authorised
that additive for 10 years for use for chickens for
fattening, turkeys for fattening and chickens reared for
laying respectively,
linking the authorisation to the
person responsible for putting that additive into circu­
lation. That additive was notified as an existing product
in accordance with Article 10 of Regulation (EC) No
1831/2003. Since all
the information required under
that provision was submitted, that additive was entered
into the Community Register of Feed Additives.

Regulation (EC) No 1831/2003 provides for the possi­
bility of modifying the authorisation of an additive
further to a request from the holder of the authorisation
and an opinion of the European Food Safety Authority
(the Authority). The holder of the authorisation of the
additive diclazuril (Clinacox 0,5 % Premix) has submitted
an application with which it proposes changing the
conditions of
a
maximum residue limit
(MRL) as evaluated by the
Authority. At the same time it provided the necessary
data to support that request.

authorisation by

introducing

the

(1) OJ L 268, 18.10.2003, p. 29.
(2) OJ L 270, 14.12.1970, p. 1.
(3) OJ L 296, 17.11.1999, p. 3.
(4) OJ L 62, 2.3.2001, p. 3.
(5) OJ L 26, 31.1.2003, p. 3.

In its opinion adopted on 16 April 2008 (6),
the
Authority concluded that no MRLs are required for
chickens and turkeys for fattening. However,
in case
it suggested values.
MRLs were considered necessary,
reared for
Because it
laying enter in the food chain, not separately from the
other chickens, it is necessary to consider the possibility
to provide MRLs also for that animal category. It also
considered that applying a withdrawal period of zero
days would not compromise consumer safety.

is possible that

the chickens

To ensure a high level of safety for the consumers and to
improve the controls of the correct use of diclazuril, it is
appropriate to establish MRLs as proposed by the
Authority. Because there are no relevant physiological
differences between the chickens
fattening and
chickens reared for laying it is appropriate to establish
the same MRLs also for the latter category.

for

Commission Regulations (EC) No 2430/1999, (EC) No
418/2001 and (EC) No 162/2003 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(4)

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

In Annex I to Regulation (EC) No 2430/1999 the line for E 771
is replaced by the text in Annex I to this Regulation.

Article 2

Annex III to Regulation (EC) No 418/2001 is replaced by the
text in Annex II to this Regulation.

(6) Updated Scientific Opinion of the Panel on Additives and Products
or Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on the Maximum Residue Limits for Clinacox
0,5 % (diclazuril) for turkeys for fattening, chickens for fattening and
chickens reared for laying. The EFSA Journal (2008) 696, 1-12.

L 266/4

EN

Official Journal of the European Union

7.10.2008

Article 3

The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal
of the European Union.

Article 4

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 October 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

7.10.2008

EN

Official Journal of the European Union

L 266/5

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